FRESH Study (Fitness, Relaxation and Eating to Stay Healthy)

Overweight Clinical Trial

— FRESH  

Official title:

Diet, Exercise, Cooking, and Stress Management for Patients With Prediabetes: A Pilot Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636258
• Other study ID #: 12-340
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: December 2012

Study information

• Verified date: May 2022
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To examine whether a lifestyle program results in weight loss and thereby delays or prevents progression of pre-diabetes to diabetes, we propose a pilot randomized controlled trial of 6 weeks duration with 30 participants held at Stephanie Tubbs Jones Health Center. Participants are randomized to receive all of the following: nutrition education, exercise instruction, stress management instruction, and culinary education or follow usual care. Outcomes include: blood sugars and cholesterol, weight, waist circumference, blood pressure, diet, physical activity, perceived stress, and class attendance. Analysis is by Intention to treat analysis of variance. Results will be used to help design larger randomized trial in the future.

Description:

Control group: These participants will continue to receive their usual care from their primary medical care team. Intervention group: The participants will receive nutrition education, exercise instruction, stress management instruction,and culinary education

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Study participants must:

1. Be capable of giving informed consent

2. Understand and voluntarily sign the informed consent form.

3. Be females at least 18 years of age and identify themselves as African-American

4. Have prediabetes as defined by the American Diabetes Association: history of glycated hemoglobin (HgbA1c) 5.7-6.4 % or fasting blood glucose 100-125 mg/dL (5.6-6.9 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose 140-199 mg/dL (7.8-11.0 mmol/L) during an oral glucose tolerance test (as described by the World Health Organization using a glucose load of 75 g anhydrous glucose dissolved in water)

5. Have a body mass index (BMI, defined as weight in kilograms divided by height in meters squared) greater than or equal to 25

Exclusion Criteria:

1. Current or previous diagnosis of diabetes or a history of HgbA1c = 6.5% or fasting blood glucose = 126 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose = 200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test or a history of classic symptoms of hyperglycemia or hyperglycemic crisis and a random plasma glucose = 200 mg/dL (11.1 mmol/L).

2. Normal glycemia or a currently with a HgbA1c < 5.7% or fasting blood glucose < 100 mg/dL (7.0 mmol/L) (fasting defined as no caloric intake for at least 8 hours), or a 2-hour plasma glucose < 140 mg/dL (11.1 mmol/L) during an oral glucose tolerance test

3. Current or past use of oral hypoglycemic agents (including, but not limited to, metformin, rosiglitazone, pioglitazone, glipizide, and glyburide) or insulin

4. Male gender

5. History of congestive heart failure

6. History of renal failure, dialysis, or creatinine greater than 2 mg/dL

7. History of liver failure or a liver dysfunction with a increase by a factor of 2 above the upper limit of normal in alanine aminotransferase or aspartate aminotransferase

8. History of gastrointestinal disorder that would prevent adherence to the recommended diet (e.g. celiac disease, inflammatory bowel disease, history of bariatric surgery, history of intestinal surgery)

9. Presence of active cancer

10. History of coronary artery disease or cerebrovascular disease

11. History of uncontrolled hypertension

12. Participation in another lifestyle modification trial

13. Pregnancy or lactating or planning to be pregnant

14. Current alcoholism or abuse of recreational drugs

15. Hospitalization for depression in past 12 months

16. Travel plans that do not permit full participation or participant lives too far from Health Center to permit full participation

17. History of bariatric surgery, small bowel resection, or extensive bowel resection

18. Chronic treatment with systemic steroids

19. Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder

20. Inability to walk two blocks

21. Other medial, psychiatric, or behavioral limitations that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol

22. Amputation of lower limb for nontraumatic causes

23. Self report of HIV-positivity or active tuberculosis

24. Documented history of pulmonary embolus in past six months

25. Chronic obstructive pulmonary disease that would limit ability to follow the study protocol

26. Self-reported chronic hepatitis B or C or cirrhosis; inflammatory bowel disease requiring treatment in past year; Cushing's syndrome; acromegaly (clinical diagnosis or self-report); any major organ transplant

27. Unwilling or uninterested in participating in group lifestyle education sessions

28. Current regular corticosteroid use

29. Active polycystic ovarian syndrome

Related Conditions & MeSH terms

• Glucose Intolerance
• Overweight
• Prediabetes
• Prediabetic State

Intervention

Behavioral:
• Stress Management
Every other week
• Diet
Every other week
• Exercise
Every week
• Culinary education
Every other week

Locations

Country	Name	City	State
United States	Stephanie Tubbs Jones Health Center	East Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of "FRESH" Program on Weight Loss	Change in weight measured at baseline and followup (at 8-14 weeks).	Baseline line and final followup visit (at 8-14 weeks)
Secondary	Diet - Daily Calorie Intake	Change in daily caloric intake as measured by online 24-hour recall dietary program	Baseline and final followup visit (at 8-14 weeks)
Secondary	Exercise	Change in 7-day average steps/day as measured by pedometer at baseline and followup (at 8-14 weeks).	Baseline and final followup visits (at 8-14 weeks)
Secondary	Stress	Change of Psychosocial Stress (PSS-10) scores (total range 0-40) measured at baseline and followup (at 8-14 weeks). Higher score reflects worse outcome.	baseline and followup visit (at 8-14 weeks)
Secondary	Sleep	Change in self-reported average hours of sleep/night measured at baseline and followup (at 8-14 weeks).	baseline and followup visit (at 8-14 weeks)